Bladder CancerPhase 2IMGeSNCT06388720
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
A Phase 2 study testing Mitomycin-C and gemcitabine in people with Bladder Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Mitomycin-C and gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Nov 2024to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a patient over the age of 20
- Patients who are willing and able to complete a written test subject consent/approval for this examination.
- Histologically confirmed high-risk NMIBC (according to AUA guidelines; High-grade T1 disease, any recurrent high-grade Ta, high-grade Ta >3 cm, high-grade Ta that is multifocal, any carcinoma in situ, any BCG failure in high-grade patients, any variant histology, any lymphovascular invasion, and any high-grade prostatic urethral involvement) with prior BCG therapy.
- The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG
- Patients who are not eligible for a radical bladder resection or who have refused surgery.
- Patient who are not being pregnant or breast feeding until the study period.
Who cannot join
- Patient diagnosed with muscle-invasive bladder cancer at TURBT
- If upper urinary tract urothelial cancer is accompanied by imaging
- If the imaging indicates extravesical involvement (cT3)
- Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
- In a biopsy, non-transitional cell histology is dominant, or only non-transitional cell tissue is present (primary squamous cell carcinoma, primary adenocarcinoma, small cell carcinoma, sarcoma, carcinosarcoma, paraganglioma, melanoma, lymphoma)
- In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
Show all 20Show fewer
- If patient have a history of pelvic radiation therapy for other cancers within 3 years
- If patient have a history of receiving Mitomycin-c or gemcitabine in the bladder within 3 years. The exception is cases used for the purpose of injection therapy of anticancer drugs in the early bladder cancer
- If patient has a history of allergy to mitomycin-c or gemcitabine
- Cystoscopy shows a tumor in the prostate urethra
- Patients who have participated in studies using clinical trial drugs and are currently receiving clinical trial drugs or who have used clinical trial drugs or clinical trial medical devices within 4 weeks prior to the date of initial treatment
- After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment
- Thrombocytopenia, coagulopathy or bleeding tendency patient.
- Pregnant or breast-feeding women
- If patient treated yellow fever vaccine or phenytoin
- Dysfunction of liver or kidney (GFP≤30)
- If patient undergo severe myelosuppression
- If patient complicated severe infection
- If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray.
- If patient conduct chest radiotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si
Ho Kyung Seo, 82-31-920-1678, seohk@ncc.re.kr
Ho Kyung Seo, MD
About this study
Official title: A Study to Assess the Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy in Patients With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to BCG Therapy
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
Read the detailed description
Phase 2 clinical, multi-institutional, open assignment prospective study
Primary Outcome Measures:
1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg/20 ml and Gemcitabine 2000 mg/50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.
Secondary Outcome Measures:
Progression Free Survival (PFS), Cystectomy free survival (CFS), Cancer specific survival (CSS), Overall survival (OS) and safety after Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.
- Conditions
- Bladder Cancer
- Being tested
- Mitomycin-C, gemcitabine
- Keywords
- high risks non-muscle invasive bladder cancer, Sequential treatment, Intravesical treatment, Mitomycin-c, Gemcitanine
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin-CDrug
Also called Sequential treatment group
Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.
gemcitabineDrug
Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml Receives: Drug: Mitomycin-C; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
High risk Recurrent free survival in sequential treatment group.
Time from initial TURBT* to first histologically confirmed recurrence of high-risk NMIBC or disease progression (per PFS definition), whichever occurs first.
Measured: 1year
Secondary outcomes (5)
Progression free survival in sequential treatment group.
defined as the period from the initial TURBT date* to the time when T stage progresses (e.g., Ta>T1, CIS>T1) (PFS1) or muscle invasive bladder cancer (T2 or higher) was first biopsy confirmed (PFS2) or imagingally diagnosed with metastasis to bladder cancer.
Measured: 1year
Cystectomy free survival in sequential treatment group.
Defined as the period from the initial TURBT date* to the time when radical cystomy was performed.
Measured: 1year
cancer specific survival in sequential treatment group.
Duration from initial TURBT date* to the time of death from bladder cancer
Measured: 1year
Overall survival in sequential treatment group.
The period from the initial TURBT date* to the point of death (regardless of cause)
Measured: 1year
Safety of sequential treatment.
The first safety analysis is conducted on test subjects who have developed toxicity in accordance with CTCAE standards. In particular, urinary disorders such as urinary tract infections and acute urination that occurred after injection of drugs into the bladder are evaluated.
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start19 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Korea University Anam Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Chonnam National University Hospital
- Responsible party
- Principal investigator, Ho Kyung Seo, National Cancer Center, Korea
- Investigators
- Ho Kyung Seo, MD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388720
- Sponsor's protocol ID
- NCC2024-0026
- Acronym
- IMGeS
- Status last verified
- May 2025
- First submitted
- 24 Apr 2024
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy in Patients With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to BCG Therapy
- ClinicalTrials.gov ID
- NCT06388720
- Acronym / sponsor ID
- IMGeS / NCC2024-0026
- Conditions
- Bladder Cancer
- Keywords
- high risks non-muscle invasive bladder cancer, Sequential treatment, Intravesical treatment, Mitomycin-c, Gemcitanine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Korea University Anam Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Chonnam National University Hospital
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
Detailed description
Phase 2 clinical, multi-institutional, open assignment prospective study
Primary Outcome Measures:
1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg/20 ml and Gemcitabine 2000 mg/50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.
Secondary Outcome Measures:
Progression Free Survival (PFS), Cystectomy free survival (CFS), Cancer specific survival (CSS), Overall survival (OS) and safety after Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Mitomycin-C, Drug: gemcitabineIntravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a patient over the age of 20
- Patients who are willing and able to complete a written test subject consent/approval for this examination.
- Histologically confirmed high-risk NMIBC (according to AUA guidelines; High-grade T1 disease, any recurrent high-grade Ta, high-grade Ta >3 cm, high-grade Ta that is multifocal, any carcinoma in situ, any BCG failure in high-grade patients, any variant histology, any lymphovascular invasion, and any high-grade prostatic urethral involvement) with prior BCG therapy.
- The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG
- Patients who are not eligible for a radical bladder resection or who have refused surgery.
Key exclusion criteria (20 listed)
- Patient diagnosed with muscle-invasive bladder cancer at TURBT
- If upper urinary tract urothelial cancer is accompanied by imaging
- If the imaging indicates extravesical involvement (cT3)
- Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
- In a biopsy, non-transitional cell histology is dominant, or only non-transitional cell tissue is present (primary squamous cell carcinoma, primary adenocarcinoma, small cell carcinoma, sarcoma, carcinosarcoma, paraganglioma, melanoma, lymphoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin-CAlso: Sequential treatment groupIntravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment. | Drug | Intervention group |
| gemcitabineIntravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration. | Drug | Intervention group |
Primary outcome
High risk Recurrent free survival in sequential treatment group.
Time frame: 1year
Time from initial TURBT* to first histologically confirmed recurrence of high-risk NMIBC or disease progression (per PFS definition), whichever occurs first.
5 secondary outcomes
Progression free survival in sequential treatment group.
Time frame: 1year
Cystectomy free survival in sequential treatment group.
Time frame: 1year
cancer specific survival in sequential treatment group.
Time frame: 1year
Overall survival in sequential treatment group.
Time frame: 1year
Safety of sequential treatment.
Time frame: 2year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ho Kyung Seo, MD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitomycin-C and gemcitabine in people with Bladder Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho Kyung Seo, MD (82-31-920-1678, seohk@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High risk Recurrent free survival in sequential treatment group. (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.